BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 8292076 · Received January 31, 2019

    Report

    Report Number
    0002648920-2019-00061
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    January 15, 2019
    Report Date
    August 12, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN STEM - UNKNOWN PART AND LOT, UNKNOWN CUP - UNKNOWN PART AND LOT. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS SHOWING THE FEMORAL HEAD IS SUPEROLATERALLY POSITIONED IN RELATION TO THE CUP. VISUAL INSPECTION OF THE FEMORAL HEAD SHOWS SCUFF MARKS ON THE ARTICULATING SURFACE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#: 00877702803, BIOLX OPT HD/ADPT 12/14 28+3.5, LOT#: 2955283. ITEM#: 00620105400, REPLACEMENT LOCKING RING FOR USE WITH 54 MM SHELL, LOT#: 63484424. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: LINER: 0001822565-2019-00353.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE AND SUBSEQUENTLY 2 1/2 YEARS LATER, THE PATIENT WAS REVISED DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86887 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER HIP PROSTHESIS LPH ZIMMER MANUFACTURING B.V. N/A 63265757

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R